质量控制培训手册 英文版 Quality Control Training Manual

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质量控制培训手册，一本非常好的质量控制方面的培训书籍，适用于原料药、成品、生物技术实验室的质量控制培训，非常专业。
Quality Control Training Manual
Contents
Preface...............................................................................................................xvii
Acknowledgements ............................................................................................xix
Authors ...............................................................................................................xxi
About the Book ................................................................................................xxiii
Disclaimer .......................................................................................................xxvii
QCT-01 Analytical Methods, Techniques and Quality Measures
for General Pharmaceutical Products ........................................... 1
QCT-01.1 Analytical Method Validation and Requirements ........................ 3
Test Methods and Standards ......................................................... 3
Test Method Validation ................................................................. 3
Test Method Transfer .................................................................... 4
Change Control ............................................................................. 4
Quality Standards Manual ............................................................ 5
Laboratory Procedures.................................................................. 5
Training ......................................................................................... 6
Testing ........................................................................................... 7
Raw Data ....................................................................................... 7
Cleaning Validation ...................................................................... 8
Raw Material................................................................................. 8
QCT-01.2 Laboratory Equipment .................................................................. 9
Calibration and Maintenance ........................................................ 9
Documentation ............................................................................ 10
Cleaning ...................................................................................... 11
Qualifi cation of the Equipment ................................................... 11
Columns’ Records ....................................................................... 12
Columns’ Evaluation ................................................................... 13
Change Control ........................................................................... 13
QCT-01.3 Reference Standards and Reagents ............................................. 15
USP and Other Pharmacopoeial Standards ................................ 15
Reagents, Standardized Volumetric Solution and Buffers .......... 16
Procedure for Internal Working Standards
(Secondary Reference Standards) Preparation ........................... 16
Stock Solutions, Working and Test Solution ............................... 18
viii Contents
Expiration and Retest Dates for Standards and Reagents ........... 18
Storage ........................................................................................ 18
Labelling ..................................................................................... 19
QCT-01.4 Sample Management ................................................................... 21
Raw Materials, Finished Products, In-Process,
Validation, Swab, Water, Air, Complaint.................................... 21
QCT-01.5 Stability Analytical Methods and Requirements ........................ 25
Written Procedures ..................................................................... 25
On Site Starts .............................................................................. 26
Time and Frequencies ................................................................. 26
Statistical Considerations ............................................................ 27
Evaluation of Stability ................................................................ 27
Specifi cations and Methods ........................................................ 28
Stability Methods ........................................................................ 30
Stability Methods Validation Program ....................................... 30
Technology Transfer ................................................................... 30
Change Control ........................................................................... 31
Raw Data ..................................................................................... 31
Training Effectiveness ................................................................ 31
Analyst-Specifi c Training ........................................................... 32
Training Documentation ............................................................. 32
Stability Chambers ..................................................................... 33
Outside Laboratories ................................................................... 33
QCT-01.6 Microbiological Methods and Analysis ...................................... 35
Microbiological Methods and Testing ........................................ 35
Microbiological Testing for Non-Sterile Products ...................... 35
Growth Promotion Testing .......................................................... 36
Media Preparation and Sterilization ........................................... 36
Outside Vendor–Supplied Media ................................................ 37
Aseptic Technique Training ........................................................ 37
Gowning ...................................................................................... 38
Sterility Testing ........................................................................... 38
Automated Identifi cation Systems .............................................. 39
Sterility Testing Facilities ........................................................... 39
Environmental Monitoring during Sterility Testing ................... 40
Water Monitoring Data ............................................................... 40
Compressed Air for Sterile Area ................................................ 41
Nitrogen Testing for Sterile Area ................................................ 41
Oxygen Testing for Sterile Area ................................................. 41
Contents ix
Preservative Effectiveness Testing .............................................. 42
Bacterial Endotoxin Testing for Sterile Products ....................... 42
QCT-01.7 Analytical Failure Investigations ................................................ 43
Laboratory Investigations ........................................................... 43
OOS Investigations ..................................................................... 44
Training on OOS Procedure ....................................................... 47
Training Documentation ............................................................. 47
QCT-01.8 Calibration Program ................................................................... 49
QC Instruments Calibration ........................................................ 49
Calibration Procedure ................................................................. 50
Calibration Frequency ................................................................. 51
Documentation ............................................................................ 52
QCT-01.9 Laboratory Facility ..................................................................... 53
General Requirements ................................................................ 53
Area for Handling Test and Reference Substances ..................... 54
Areas for Routine Samples after Complete Testing .................... 54
Reference Samples after Expiry ................................................. 55
Archive Room ............................................................................. 55
Storage of Bacterial Strains ........................................................ 56
Cleaning, Disinfecting and Washing Glass Apparatus ............... 56
Utilities ........................................................................................ 57
Safety Shower ............................................................................. 57
QCT-01.10 Products Annual Reviews ........................................................... 59
Annual Reviews .......................................................................... 59
Written Procedures ..................................................................... 59
Management Review ................................................................... 60
Data Reliability ........................................................................... 61
Use of Ongoing Statistics ............................................................ 61
Follow-up .................................................................................... 61
QCT-01.11 Third-Party Testing ..................................................................... 63
General ........................................................................................ 64
QCT-01.12 Good Documentation Practices .................................................. 65
Documentation ............................................................................ 65
Procedure .................................................................................... 65
x Contents
QCT-01.13 Change Control ........................................................................... 67
Unplanned Changes .................................................................... 68
Planned Changes ......................................................................... 68
Routine Changes (Documentation) ............................................. 68
QCT-02 Analytical Methods, Techniques and Quality Measures
for Biological Products ............................................................... 71
QCT-02.1 Immunoblotting .......................................................................... 73
Immunoblotting Analytical Technique ....................................... 73
Procedure .................................................................................... 74
Enhanced Chemiluminescence ................................................... 76
QCT-02.2 Gel Permeation Chromatography ............................................... 79
Basic Philosophy ......................................................................... 79
Mechanism of Gel Permeation Chromatography ....................... 81
Advantages of GPC ..................................................................... 81
Disadvantages ............................................................................. 82
QCT-02.3 Electrophoresis ............................................................................ 85
Gel Electrophoresis ..................................................................... 85
DNA Electrophoresis .................................................................. 86
One-Dimensional (1D) Electrophoresis ...................................... 87
Two-Dimensional (2D) Electrophoresis ...................................... 88
Capillary Electrophoresis ........................................................... 88
Capillary Zone Electrophoresis .................................................. 90
Capillary Gel Electrophoresis ..................................................... 90
Capillary Isoelectric Focusing .................................................... 90
QCT-02.4 Ion-Exchange Chromatography .................................................. 93
Effect of Charge on the Protein Molecule .................................. 94
Protein Separation by IEC .......................................................... 95
Anion-Exchange Chromatography ............................................. 96
Cation-Exchange Chromatography ............................................. 96
QCT-03 Laboratory Training Manual ...................................................... 99
QCT-03.1 Laboratory Safety and Good Laboratory Practice ....................101
Procedure ...................................................................................101
Good Laboratory Practices ....................................................... 104
Contents xi
QCT-03.2 Training of Sampling Procedure............................................... 107
Procedure .................................................................................. 107
QCT-03.3.1 Training of Conventional Procedures ........................................113
Procedure ...................................................................................113
QCT-03.3.2 Training of Basic Analytical Techniques ..................................115
Weighing ....................................................................................115
Volumetric Techniques ..............................................................116
Defi nitions ..................................................................................116
Use of Burette ............................................................................116
Temperature Measurement and Control ....................................117
Heating .......................................................................................117
Cooling .......................................................................................117
Mechanical Methods of Separation ...........................................117
Limit Tests .................................................................................118
Determination of Weight per Millilitre Density/Solids .............119
Physical Observations ............................................................... 120
QCT-03.3.3 Training of Chromatographic Techniques ................................ 121
Testing to Specifi cation/Practical Work ................................... 121
Chromatographic Techniques ................................................... 121
HPLC Pumping System ............................................................ 122
Injectors .................................................................................... 123
Columns .................................................................................... 123
Detectors ................................................................................... 124
Solvents and Reagents ............................................................... 125
Data Handling and Interpretation ............................................. 125
Gas Chromatography ................................................................ 126
Sample Injection ....................................................................... 126
Types of Columns ..................................................................... 126
Injectors .................................................................................... 127
Detectors ................................................................................... 127
Procedure .................................................................................. 127
QCT-03.3.4 Spectroscopic Techniques ..........................................................131
UV Absorption and Colorimetry ...............................................131
Infrared Spectrophotometry ..................................................... 132
Atomic Absorption Spectrometry ............................................. 132
Instrumentation ......................................................................... 133
Sample Preparation and Vaporization ...................................... 134
xii Contents
Interferences and Quantitative Measurements.......................... 134
Trainee Assessment .................................................................. 135
Flame Emission Spectrometry .................................................. 135
Sample Preparation and Vaporization ...................................... 136
Interference and Quantitative Measurements ........................... 136
Trainee Assessment .................................................................. 137
QCT-03.3.5 Electrochemical Techniques ..................................................... 139
pH Measurement and Ion-Selective Electrodes ........................ 139
Potentiometer Titrations, if Available ....................................... 140
Biamperometric Titrations ........................................................ 140
Karl Fischer Titrations .............................................................. 140
Automatic Titrations ..................................................................141
QCT-03.3.6 Dissolution Test ..........................................................................143
QCT-03.3.7 Miscellaneous Techniques ........................................................ 145
Polarimetry ............................................................................... 145
Particle Size Analysis ............................................................... 146
Suppository Penetration Tester ................................................. 146
Viscometry .................................................................................147
Other Analytical Techniques .....................................................147
QCT-04 Assessment of Training ............................................................. 149
QCT-04.1 Assessment Procedure for Chemical Testing ........................... 151
Procedure .................................................................................. 151
Use of Balance and Volumetric Techniques ............................. 151
Titration with 1.0 M Hydrochloric Acid ................................... 151
Quantitative Transfer of Sodium Hydroxide ............................. 152
Temperature Measurement and Control ................................... 152
Solvent Extraction Exercise ...................................................... 153
Exercise for Limit Tests ............................................................ 153
Determination of Weight per mL and Density of Solid ............ 155
Physical Observation ................................................................. 155
Testing to Specifi cation/Practical Work ................................... 155
Chromatographic Techniques ................................................... 155
Assessment Procedures for GC and HPLC .............................. 156
Test Procedure........................................................................... 157
Criteria for Assessment ............................................................. 159
Contents xiii
QCT-04.2 Assessment Procedure for Microbiologist .................................161
Procedure ...................................................................................161
Use of Balance and Volumetric Techniques ..............................161
Temperature Measurement and Control ....................................161
Media Preparation ..................................................................... 162
Glassware Preparation .............................................................. 162
Aseptic Technique ..................................................................... 162
Autoclaves ................................................................................. 162
Testing to Specifi cation/Practical Work ................................... 163
Microbiological Assays ............................................................. 163
pH Measurement ....................................................................... 164
Environmental Monitoring ....................................................... 164
Aerobic Microbial Counts Organism Identifi cation ................. 164
Maintenance of Cultures and Organism Identifi cation ............. 165
QCT-05 Training Assessment with Quiz and Answers .......................... 167
QCT-05.1 Assessment for Analytical Methods Validation and
Requirements ............................................................................ 169
QCT-05.1.1 Answers to Quiz for Analytical Methods Validation and
Requirements .............................................................................173
QCT-05.2 Assessment for Analytical Equipment ...................................... 177
QCT-05.2.1 Answers to Quiz for Analytical Equipment ............................. 183
QCT-05.3 Assessment for Reference Standards and Reagents .................. 187
QCT-05.3.1 Answers to Quiz for Reference Standards and Reagents ......... 193
QCT-05.4 Assessment for Sample Management ....................................... 197
QCT-05.4.1 Answers to Quiz for Sample Management ............................... 201
QCT-05.5 Assessment for Stability Analytical Methods and
Requirements ............................................................................ 205
QCT-05.5.1 Answers to Quiz for Stability Analytical Methods and
Requirements .............................................................................211
xiv Contents
QCT-05.6 Assessment for Microbiological Methods and Testing ............... 215
QCT-05.6.1 Answers to Quiz for Microbiological Methods and Testing ......219
QCT-05.7 Assessment for Laboratory Investigations ................................ 223
QCT-05.7.1 Answers to Quiz for Laboratory Investigations ........................ 229
QCT-05.8 Assessment for Calibration Programme ................................... 233
QCT-05.8.1 Answers to Quiz for Calibration Programme ........................... 239
QCT-05.9 Assessment for Laboratory Facility .......................................... 243
QCT-05.9.1 Answers to Quiz for Laboratory Facility .................................. 249
QCT-05.10 Assessment for Annual Reviews ............................................... 253
QCT-05.10.1 Answers to Quiz for Annual Reviews ...................................... 257
QCT-05.11 Assessment for Third-Party Testing ......................................... 259
QCT-05.11.1 Answers to Quiz for Third-Party Testing ................................. 263
QCT-05.12 Assessment for Good Documentation Practices ....................... 265
QCT-05.12.1 Answers to Quiz for Good Documentation Practices ............... 269
QCT-05.13 Assessment for Change Control ................................................ 271
QCT-05.13.1 Answers to Quiz for Change Control........................................ 275
QCT-05.14 Assessment for Immunoblotting ............................................... 277
QCT-05.14.1 Answers to Quiz for Immunoblotting ....................................... 281
QCT-05.15 Assessment for Gel Permeation Chromatography .................... 283
QCT-05.15.1 Answers to Quiz for Gel Permeation Chromatography ............ 289
QCT-05.16 Assessment for Electrophoresis ................................................ 293
QCT-05.16.1 Answers to Quiz for Electrophoresis ........................................ 299
Contents xv
QCT-05.17 Assessment for Ion-Exchange Chromatography ....................... 303
QCT-05.17.1 Answers to Quiz for Ion-Exchange Chromatography............... 307
QCT-06 Training Log ............................................................................. 309
QCT-06.1 General Introduction Training Log............................................311
General Introduction of Company and Department ..................311
QCT-06.2 Good Housekeeping and Good Laboratory Practice .................313
Good Housekeeping Safety and GLP ........................................313
QCT-06.3 Sampling Procedure Training Log ............................................315
Training of Sampling Procedure................................................315
QCT-06.4 Chemical Testing Training Log .................................................317
Training of Chemical Testing ....................................................317
QCT-06.5 Training Log for Microbiology ................................................. 323
QCT-07 Analytical Method Validation Master Plan .............................. 327
Purpose ..................................................................................... 328
Introduction ............................................................................... 328
Scope and Approach ................................................................. 329
Method Validation Team Responsibilities ................................ 333
Method Validation Strategies .................................................... 334
New Products, Methods and Instruments ................................. 335
Revalidation .............................................................................. 336
Protocol Development Phase .................................................... 336
Selectivity and Specifi city......................................................... 337
Precision and Reproducibility ................................................... 338
Accuracy and Recovery ............................................................ 339
Linearity and Calibration Curve ............................................... 339
Range ........................................................................................ 340
Limit of Detection and Quantitation ......................................... 340
Robustness ................................................................................ 340
Acceptance Criteria .................................................................. 341
Analytical Results Reporting .................................................... 341
Incident Investigation ................................................................ 341
xvi Contents
Validation Reports .................................................................... 341
Change Control/Revalidation ................................................... 342
QCT-08 Analytical Methods Validation Protocol .................................. 343
Purpose ..................................................................................... 344
Introduction ............................................................................... 344
Materials and Equipment .......................................................... 344
Responsibilities ......................................................................... 345
Defi nitions ................................................................................. 345
Procedure .................................................................................. 346
QCT-09 SOP for Annual Re-Qualifi cation of HPLC Units .................... 349
Purpose ..................................................................................... 349
Scope ......................................................................................... 349
Responsibilities ......................................................................... 349
HPLC Qualifi cation .................................................................. 349
Attachment ................................................................................ 350
Procedure .................................................................................. 350
Form No. 1 ................................................................................ 355
QCT-10 SOP for Annual Re-Qualifi cation of GC Units ........................ 357
Purpose ..................................................................................... 357
Scope ......................................................................................... 357
Responsibilities ......................................................................... 357
HPLC Qualifi cation .................................................................. 357
Attachment ................................................................................ 358
Procedure .................................................................................. 358
Form No. 1 ................................................................................ 363
QCT-11 ABC Pharmaceutical Company ................................................ 365
Good Laboratory Practices ....................................................... 365
QCT-12 Regulations ............................................................................... 371
Index ................................................................................................................. 449

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胜利者

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胜利者

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yang_2113963A

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globle001

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86419405

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yang_2113963A

感谢楼主分享